Sponsored Webcast: Systematic Literature Review to Help Meet MDR Requirements

Companies face constant pressure to meet the increasing regulatory expectations and demands for information. Data identification through Systematic Literature Review (SLR) supports critical regulatory functions throughout the company, from MDR requirements through IND submissions.

In this session, we will review:

• How the use of published data can support regulatory expectations
• When to conduct a systematic literature review
• Best practices for conducting a methodologically-sound SLR
• The tools and technology available for SLR
• Real world case studies about leveraging SLR

Learning Objectives

Upon conclusion of the program, you will be able to:

• Understand how published data can be used to support regulatory expectations
• Determine when to conduct a systematic literature review
• Understand the best practices for conducting a methodologically-sound SLR
• Have knowledge of using the available SLR tools and technology

Who Should Attend?

• Anyone utilizing literature review for regulatory submissions or data identification, from entry-level to experienced professionals.

Speaker

• Laurie Mitchell, President, Criterion Edge

Laurie Mitchell is Founder and President of Criterion Edge, a global medical and regulatory writing and safety services firm serving the medical device, pharmaceutical, and biotech industries. Laurie has over 20 years of experience in medical writing, safety and pharmacovigilance management, and regulatory reporting. Having provided regulatory solutions to many pharma and medical device companies, both large and small, she is a proven leader in designing practical strategies to meet current global regulatory challenges. Laurie is a published author, and holds a Master of Nursing from UCLA.

Webcast registration includes access to handouts, presentation slides and the on-demand recording for one year.